Staging medical treatment using ultrasound

ABSTRACT

A method for medical treatment of a patient. An ultrasound imaging transducer assembly is obtained. The assembly is inserted into a gastrointestinal area of the patient. The assembly is guided within the gastrointestinal area. Patient tissue in the gastrointestinal area is identified for medical treatment. The medical treatment is staged from ultrasound imaging using the assembly. The patient tissue is medically treated according to the staging. In one example, the medical treatment is not ultrasound medical treatment. In another example, the ultrasound imaging transducer assembly is an ultrasound imaging and medical-treatment transducer assembly which is used for the medical treatment.

[0001] The present application claims priority of U.S. ProvisionalApplication Serial No. 60/294,135 filed May 29, 2001, the entiredisclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates generally to ultrasound, and moreparticularly to an ultrasound medical system and/or to an ultrasoundmedical method.

BACKGROUND OF THE INVENTION

[0003] Known ultrasound medical systems and methods include usingultrasound imaging of patients to identify patient tissue for medicaltreatment and include using ultrasound to medically destroy identifiedpatient tissue by heating the tissue. Imaging is done at lower power andmedical treatment is done at higher power. Low power imaging ultrasoundwill not medically affect patient tissue. High power medical-treatmentultrasound, when focused at a focal zone a distance away from theultrasound source, will substantially medically affect patient tissue inthe focal zone. However, focused medical-treatment ultrasound will notsubstantially medically affect patient tissue outside the focal zonesuch as patient tissue located between the source and the focal zone.

[0004] In one known example, a transducer assembly includes a singleultrasound transducer having a single transducer element, or an array oftransducer elements acting together, to ultrasonically image the patientand to ultrasonically ablate identified patient tissue. It is known toconvert ultrasound imaging data into temperature imaging data forultrasound-treated patient tissue to monitor the ultrasound treatment. Aknown transducer element includes a transducer element having a concaveshape or an acoustic lens to focus ultrasound energy. A known array oftransducer elements includes a planar, concave, or convex array oftransducer elements to focus ultrasound energy. A known array oftransducer elements includes an array whose transducer elements areelectronically or mechanically controlled together to steer and focusthe ultrasound emitted by the array to a focal zone (which may be largeor which may be as small as, for example, a grain of rice) to providethree-dimensional medical ultrasound treatment of patient tissue. Insome applications, the transducer is placed on the surface of patienttissue for ultrasound imaging and/or ultrasound medical treatment ofareas within the patient tissue. In other applications, the transduceris surrounded with a balloon which is expanded to contact the surface ofpatient tissue by filling with a fluid such as a saline solution toprovide acoustic coupling between the transducer and the patient tissue.

[0005] Known ultrasound medical systems and methods include deploying anend effector having an ultrasound transducer outside the body to breakup kidney stones inside the body, endoscopically inserting an endeffector having an ultrasound transducer in the colon to medicallydestroy prostate cancer, laparoscopically inserting an end effectorhaving an ultrasound transducer in the abdominal cavity to medicallydestroy a cancerous liver tumor, intravenously inserting a catheter endeffector having an ultrasound transducer into a vein in the arm andmoving the catheter to the heart to medically destroy diseased hearttissue, and interstitially inserting a needle end effector having anultrasound transducer needle into the tongue to medically destroy tissueto reduce tongue volume to reduce snoring. Known methods for guiding anend effector within a patient include guiding the end effector fromx-rays, from MRI images, and from ultrasound images obtained using theultrasound transducer. Known ultrasound imaging includes Dopplerultrasound imaging to detect blood flow, and a proposed known use ofultrasound includes using an ultrasound transducer outside the body tostop internal bleeding (by sealing ruptured blood vessels) of a patientbrought to an emergency room of a hospital.

[0006] A Mammotome® Breast Biopsy System manufactured by EthiconEndo-Surgery, Inc. (a Johnson & Johnson Company) inserts a tube intobreast tissue, wherein the tube contains an end effector having a biopsycutting tool. A known electromagnetic transponder and three-receiversystem for calculating the position of the transponder and for guidingthe transponder (which is attached to a heart catheter for monitoringthe heart) inside a patient is the CARTO™ EP Navigation System used witha NAVI-STAR® catheter manufactured by Biosense Webster (a Johnson &Johnson Company). Further, it is known that changes in patient tissuebecause of medical treatment of patient tissue, such as ultrasoundmedical treatment, affect the amplitude and/or phase of ultrasoundimaging signals.

[0007] What is needed is an improved ultrasound medical system and/or animproved ultrasound medical method. This invention addresses those needslacking in an ultrasonic medical system and/or an ultrasonic medicalmethod.

SUMMARY OF THE INVENTION

[0008] One method of the invention is for medical treatment of a patientand includes steps a) through f). Step a) includes obtaining anultrasound imaging transducer assembly. Step b) includes inserting thetransducer assembly into a gastrointestinal area of the patient. Step c)includes guiding the transducer assembly within the gastrointestinalarea. Step d) includes identifying patient tissue in thegastrointestinal area for medical treatment. Step e) includes stagingthe medical treatment from ultrasound imaging using the transducerassembly. Step f) includes medically treating the patient tissueaccording to the staging of step e). In one example, the medicaltreatment is not ultrasound medical treatment. In another example, theultrasound imaging transducer assembly is an ultrasound imaging andmedical-treatment transducer assembly which is used for the medicaltreatment.

[0009] The present invention has, without limitation, application inconventional endoscopic and open surgical instrumentation as well asapplication in robotic-assisted surgery.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010]FIG. 1 is a perspective view of a first embodiment of the presentinvention showing an ultrasound medical treatment system which includesa tissue-retaining device;

[0011]FIG. 2 is an enlarged view of the end effector of the ultrasoundmedical treatment system of FIG. 1;

[0012]FIG. 3 is a view of the end effector of FIG. 2 retaining anintervertebral disk of a patient;

[0013]FIG. 4 is a perspective view of a first alternate end effectorwhich can be used in the ultrasound medical treatment system of FIG. 1;

[0014]FIG. 5 is a perspective view of a second alternate end effectorwhich can be used in the ultrasound medical treatment system of FIG. 1;

[0015]FIG. 6 is a perspective view of a third alternate end effectorwhich can be used in the ultrasound medical treatment system of FIG. 1;

[0016]FIG. 7 is a side elevational view of a second embodiment of thepresent invention showing another ultrasound medical treatment systemwhich includes a tissue-retaining device;

[0017]FIG. 8 is an enlarged, partially-cutaway view of the end effectorof the ultrasound medical treatment system of FIG. 7;

[0018]FIG. 9 is a perspective view of a third embodiment of the presentinvention showing an ultrasound medical system which includes flexiblefingers, wherein each finger includes an ultrasound transducer;

[0019]FIG. 10 is an enlarged view of the tube and the flexible fingersof the ultrasound medical system of FIG. 9 showing the flexible fingersin a deployed fan-like state;

[0020]FIG. 11 is a view of the flexible fingers of FIG. 10 shown in astowed state;

[0021]FIG. 12 is a perspective view of an alternate flexible fingerarrangement which can be used in the ultrasound medical system of FIG.9, showing the flexible fingers in a deployed claw-like statesurrounding patient tissue;

[0022]FIG. 13 is a perspective view of a fourth embodiment of thepresent invention showing an ultrasound medical system which includes anultrasound transducer assembly which includes at least two ultrasoundtransducers;

[0023]FIG. 14 is an enlarged view of the ultrasound transducer assemblyof the ultrasound medical system of FIG. 13;

[0024]FIG. 15 is a cross-sectional view of the transducer assembly ofFIG. 14;

[0025]FIG. 16 is a cross-sectional view of a first alternate transducerarrangement which can be used in place of the arrangement of FIG. 15;

[0026]FIG. 17 is a cross-sectional view of a second alternate transducerarrangement which can be used in place of the arrangement of FIG. 15;

[0027]FIG. 18 is a perspective view of a fifth embodiment of the presentinvention showing an ultrasound medical treatment system which includesa cutting tool and an ultrasound medical-treatment transducer assembly;

[0028]FIG. 19 is an enlarged, cross-sectional view of the tube of FIG.18 showing a cutting tool that has been introduced into the lumen of thetube;

[0029]FIG. 20 is an enlarged, cross-sectional view of the tube of FIG.18 showing an ultrasound medical-treatment transducer assembly that hasbeen introduced into the lumen of the tube;

[0030]FIG. 21 is a block diagram of an eighth method of the presentinvention which includes ultrasound staging of medical treatment ofpatient tissue in the gastrointestinal area;

[0031]FIG. 22 is a block diagram of an eleventh method of the presentinvention which includes ultrasound medical treatment of a lesion on orin the lung of a patient;

[0032]FIG. 23 is a block diagram of a thirteenth method of the presentinvention which includes ultrasound medical treatment of a blood vesselto stop the supply of blood to a lesion from the blood vessel;

[0033]FIG. 24 is a perspective view of a sixth embodiment of the presentinvention showing a portion of an ultrasound medical treatment systemwhich includes receivers for locating the position of the transducerassembly of the system; FIG. 25 is a perspective view of a seventhembodiment of the present invention showing a portion of anotherultrasound medical treatment system which includes receivers forlocating the position of the transponder of the system;

[0034]FIG. 26 is a block diagram of a seventeenth method of the presentinvention which includes aiming the transducer assembly; and

[0035]FIG. 27 is a block diagram of a twentieth method of the presentinvention which includes creating an image after starting medicaltreatment using an imaging ultrasound wave before medical treatment andan imaging ultrasound wave after starting medical treatment.

DETAILED DESCRIPTION OF THE INVENTION

[0036] Before explaining the present invention in detail, it should benoted that the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The illustrative embodiments ofthe invention may be implemented or incorporated in other embodiments,variations and modifications, and may be practiced or carried out invarious ways. Furthermore, unless otherwise indicated, the terms andexpressions employed herein have been chosen for the purpose ofdescribing the illustrative embodiments of the present invention for theconvenience of the reader and are not for the purpose of limiting theinvention.

[0037] It is understood that any one or more of the following-describedembodiments, expressions of embodiments, examples, methods, etc. can becombined with any one or more of the other following-describedembodiments, expressions of embodiments, examples, methods, etc. Forexample, and without limitation, any of the end effectors can be used inany of the methods, any of the transducer arrangements can be used inany of the end effectors, and any appropriate methods can be combinedsuch as combining the seventeenth and twentieth methods, etc.

Ultrasound Medical Treatment Using Tissue-Retaining Devices

[0038] Tissue-Retaining System for Ultrasound Medical Treatment

[0039] Referring now to the drawings, FIGS. 1-3 illustrate a firstembodiment of the present invention. A first expression of the firstembodiment of the present invention is for an ultrasound medicaltreatment system 10 including an end effector 12 insertable into apatient 14. The end effector 12 includes a tissue-retaining device 16.The tissue-retaining device 16 includes a first tissue-retaining member18 having an (i.e., at least one) ultrasound medical-treatmenttransducer 20 (also called “transducer 20”) and includes a secondtissue-retaining member 22. The first and second tissue-retainingmembers 18 and 22 are operatively connected together to retain patienttissue 24 between the first and second tissue-retaining members 18 and22 and to release patient tissue 24 so retained.

[0040] It is noted that an ultrasound medical-treatment transducer is anultrasound transducer adapted at least for ultrasound medical treatmentof a patient such as, but not limited to, a human patient. An ultrasoundmedical-treatment transducer includes either a single ultrasoundmedical-treatment transducer element or an array of ultrasoundmedical-treatment transducer elements, as is known to those skilled inthe art. An ultrasound medical-treatment transducer may or may not alsobe adapted for ultrasound imaging of a patient. Likewise, an ultrasoundimaging transducer is an ultrasound transducer adapted at least forultrasound imaging of a patient and may or may not also be adapted forultrasound medical-treatment of a patient.

[0041] Advantages of retaining patient tissue between twotissue-retaining members during ultrasound medical treatment by one ofthe tissue-retaining members include having a single instrument whichultrasonically medically treats patient tissue and at the same timeimmobilizes patient tissue against undesired movement during thetreatment. It is also noted that in one application the tissue-retainingdevice is a clamp which retains and holds tissue and that in anotherapplication the tissue-retaining device retains tissue against movement,but does not hold tissue, and therefore is not a clamp.

[0042] In one variation, not shown, the second tissue-retaining member22 has an ultrasound imaging and/or medical treatment transducer. In thesame or a different variation, not shown, the tissue-retaining device 16has at least one additional tissue-retaining member. Mechanisms, notshown, for remotely moving two (or more) members toward and away fromeach other are within the ordinary level of skill of the artisan andinclude, without limitation, the use of pivotal member attachments andthe use of cables or motors. In the same or a different variation, theretained patient tissue 24 is retained between the ultrasoundmedical-treatment transducer 20 and the second tissue-retaining member22. In the same or a different variation, the ultrasoundmedical-treatment transducer 20 focuses ultrasound energy, such focusingbeing known to those skilled in the art. In the same or a differentvariation, not shown, the second tissue-retaining member 22 issubstantially ultrasonically non-reflective.

[0043] A second expression of the first embodiment of the presentinvention is for an ultrasound medical treatment system 10 including anend effector 12 insertable into a patient 14. The end effector 12includes a tissue-retaining device 16. The tissue-retaining device 16includes a first tissue-retaining member 18 having an (i.e., at leastone) ultrasound imaging and medical-treatment transducer 26 (also called“transducer 26”) and includes a second tissue-retaining member 22. Thefirst and second tissue-retaining members 18 and 22 are operativelyconnected together to retain patient tissue 24 between the first andsecond tissue-retaining members 18 and 22 and to release patient tissue24 so retained.

[0044] It is noted that an ultrasound imaging and medical-treatmenttransducer is an ultrasound transducer adapted at least for bothultrasound imaging and ultrasound medical treatment of a patient. Anultrasound imaging and medical-treatment transducer includes either asingle ultrasound imaging and medical-treatment transducer element or anarray of ultrasound medical transducer elements (including an arrayhaving at least one separate element for imaging and at least oneseparate element for medical treatment or an array having at least twoelements each adapted for both imaging and medical treatment), as isknown to those skilled in the art. In one variation, the retainedpatient tissue 24 is retained between the imaging and medical-treatmenttransducer 26 and the second tissue-retaining member 22. In the same ora different variation, the ultrasound imaging and medical-treatmenttransducer 26 focuses ultrasound energy. In the same or a differentvariation, not shown, the second tissue-retaining member 22 issubstantially ultrasonically non-reflective.

[0045] A third expression of the first embodiment shown in FIGS. 1-3 isfor an ultrasound medical treatment system 10 including an end effector12 insertable into a patient 14. The end effector 12 includes atissue-retaining device 16. The tissue-retaining device 16 includes afirst tissue-retaining member 18 having an (i.e., at least one)ultrasound medical-treatment transducer 20 and includes a secondtissue-retaining member 22 having an (i.e., at least one) ultrasoundreflector 28. The first and second tissue-retaining members 18 and 22are operatively connected together to retain patient tissue 24 betweenthe first and second tissue-retaining members 18 and 22 and to releasepatient tissue 24 so retained.

[0046] Advantages of retaining patient tissue between twotissue-retaining members during ultrasound medical treatment by anultrasound medical-treatment transducer of a first tissue-retainingmember and an ultrasound reflector of a second tissue-retaining memberinclude having a single instrument which ultrasonically medically treatspatient tissue by direct ultrasound, which enhances the ultrasoundmedical treatment by reflected ultrasound, and which at the same timeimmobilizes patient tissue against undesired movement during thetreatment.

[0047] It is noted that an ultrasound reflector 28 is a material whichreflects ultrasound at least to a degree that would substantiallymedically affect patient tissue over a treatment period by directultrasound which is being reflected back by the ultrasound reflector.Choices of ultrasound reflecting materials include, without limitation,acoustically-rigid materials such as stainless steel (which reflectsabout 100%) and aluminum (which reflects about 80%) andacoustically-softer materials such as corporene (which reflects about90%). An ultrasound reflecting material is contrasted with an ultrasoundabsorbing material such as, without limitation, rubber or plastic. Inone variation, the retained patient tissue 24 is retained between theultrasound medical-treatment transducer 20 and the ultrasound reflector28. In the same or a different variation, the ultrasoundmedical-treatment transducer 20 and the ultrasound reflector 28 eachfocus ultrasound energy, such ultrasound reflector focusing beingaccomplished by the shape of, or by shaping, the reflector surface as iswithin the ordinary level of skill of the artisan.

[0048] A fourth expression of the first embodiment shown in FIGS. 1-3 isfor an ultrasound medical treatment system 10 including an end effector12 insertable into a patient 14. The end effector 12 includes atissue-retaining device 16. The tissue-retaining device 16 includes afirst tissue-retaining member 18 having an (i.e., at least one)ultrasound imaging and medical-treatment transducer 26 and includes asecond tissue-retaining member 22 having an (i.e., at least one)ultrasound reflector 28. The first and second tissue-retaining members18 and 22 are operatively connected together to retain patient tissue 24between the first and second tissue-retaining members 18 and 22 and torelease patient tissue 24 so retained. In one variation, the retainedpatient tissue 24 is retained between the ultrasound imaging andmedical-treatment transducer 26 and the ultrasound reflector 28. In thesame or a different variation, the ultrasound imaging andmedical-treatment transducer 26 and the ultrasound reflector 28 eachfocus ultrasound energy.

[0049] In one example of the previously-described third and fourthexpressions of the first embodiment, the ultrasound reflector 28 isdisposed to receive ultrasound energy from the transducer 20 and 26 andis oriented to reflect the received ultrasound energy back into patienttissue 24 retained by the tissue-retaining device 16. In the same or adifferent example, the ultrasound reflector 28 is oriented to reflectthe received ultrasound energy away from the transducer 20 and 26 whenthe patient tissue 14 is retained by the tissue-retaining device 16. Anadvantage of this arrangement is that it avoids damage to the transducerfrom the reflected ultrasound. In the same or a different example, oneof the first and second tissue-retaining members 18 and 22 iscontrollably orientatable relative to the other of the first and secondtissue-retaining members 18 and 22 such as, without limitation, by beingorientatable along the double-headed arrows shown in FIG. 2. In onemodification, the second tissue-retaining member 22 is controllablyorientatable relative to the first tissue-retaining member 18 to reflectthe received ultrasound energy back along different directions. A firstalternate end effector 30 is shown in FIG. 4 wherein the secondtissue-retaining member 32 is controllably orientatable relative to thefirst tissue-retaining member 34 as shown by the double-headed arrows inFIG. 4. Mechanisms, not shown, for remotely controlling the orientationof one member relative to another member are within the ordinary levelof skill of the artisan and include, without limitation, the use ofpivotal member attachments and the use of cables or motors. In oneapplication, the transducer 20 and 26 generates wide-focused ultrasound(shown by the two single-headed arrows coming from the firsttissue-retaining member 18 in FIG. 3) and the ultrasound reflector 28generates narrow-focused ultrasound (shown by the two single-headedarrows coming from the second tissue-retaining member 22 in FIG. 3).

[0050] In one example of the previously-described first through fourthexpressions of the first embodiment, the end effector 12 is anopen-surgery end effector, an endoscopic end effector, a laparoscopicend effector (as shown in FIG. 1), a catheter end effector (such as, butnot limited to, an intravascular catheter end effector), or a needle endeffector, as can be appreciated by those skilled in the art. In oneapplication, the end effector 12 is used to retain a blood vessel andthen to ultrasonically treat the blood vessel to seal the blood vesselstopping the flow of blood in the retained blood vessel. In anotherapplication, the end effector 12 is used to retain patient tissue andthen to ultrasonically ablate at least a portion of the retained patienttissue.

[0051] In one design of the previously-described first through fourthexpressions of the first embodiment, the end effector 12 has alongitudinal axis 35, and one of the first and second tissue-retainingmembers 18 and 22 at all times faces along a direction which issubstantially perpendicular to the longitudinal axis 35. If the onetissue-retaining member were planar, this means that the longitudinalaxis would be substantially parallel to the plane of the onetissue-retaining member. In one enablement, the one tissue-retainingmember is the first tissue-retaining member 18. A second alternate endeffector 36 has first and second tissue-retaining members 38 and 40which are hinged together to relatively move as indicated by thedouble-headed arrow and which are shown in a partially openconfiguration in FIG. 5. The second alternate end effector 36 has alongitudinal axis 42, and one of the first and second tissue-retainingmembers 38 and 40 at all times faces along a direction which issubstantially parallel to the longitudinal axis 42. If the onetissue-retaining member were planar, this means that the longitudinalaxis would be substantially perpendicular to the plane of the onetissue-retaining member. In one enablement, the one tissue-retainingmember is the first tissue-retaining member 38. A third alternate endeffector 37 having first and second tissue-retaining members 39 and 41with one member longitudinally movable with respect to the other member(as indicated by the double-headed arrow) is shown in FIG. 6. The thirdalternate end effector 37 has a longitudinal axis 43, and one of thefirst and second tissue-retaining members 39 and 41 at all times facesalong a direction which is substantially parallel to the longitudinalaxis 43. In one enablement, the one tissue-retaining member is the firsttissue-retaining member 39.

[0052] In one enablement, as shown in FIG. 1, the ultrasound medicaltreatment system 10 also includes a handpiece 44 operatively connectedto the end effector 12 and to an ultrasound controller 46 operativelyconnected to a foot-pedal power switch 47, as can be appreciated bythose skilled in the art.

[0053] A first method of the invention is for ultrasound medicaltreatment of a patient and uses the ultrasound medical treatment systemas previously described in the first, second, third or fourth expressionof the first embodiment with or without the previously-describedvariations, etc. thereof. The first method includes steps a) through e).Step a) includes endoscopically inserting the end effector into an ear,nose, or throat of the patient. Step b) includes guiding the endeffector in the patient. Step c) includes identifying patient tissue formedical treatment such as optionally at least in part from ultrasoundimaging using the transducer. Other ways of identifying patient tissuefor medical treatment include, without limitation, using x-rays and/orMRI imaging, as are known to the artisan. Step d) includes retaining theidentified patient tissue using the tissue-retaining device. Step e)includes medically treating the retained patient tissue with ultrasoundusing the transducer or using the transducer and the ultrasoundreflector. In one implementation, one tissue-retaining member at alltimes faces along a direction which is substantially parallel to thelongitudinal axis of the end effector (as seen in FIGS. 5 and 6).

[0054] A second method of the invention is for ultrasound medicaltreatment of a patient and uses the ultrasound medical treatment systemas previously described in the first, second, third or fourth expressionof the first embodiment with or without the previously-describedvariations, etc. thereof. The second method includes steps a) throughc). Step a) includes inserting the end effector 12 into the patient.Step b) includes retaining an intervertebral disk 48 (see FIG. 3) of thepatient with the tissue-retaining device, wherein the intervertebraldisk 48 includes tissue. Step c) includes medically treating theretained intervertebral disk 48 with ultrasound to shrink the tissueusing the transducer or using the transducer and the ultrasoundreflector. In one implementation, one tissue-retaining member at alltimes faces along a direction which is substantially perpendicular tothe longitudinal axis of the end effector (as seen in FIGS. 2 and 4). Inone application of the second method of the invention, theintervertebral disk 48 includes connective and nerve tissue.

[0055] A third method of the invention is for ultrasound medicaltreatment of a patient and uses the ultrasound medical treatment systemas previously described in the first, second, third or fourth expressionof the first embodiment with or without the previously-describedvariations, etc. thereof. The third method includes steps a) through c).Step a) includes inserting the end effector into the patient. Step b)includes retaining a joint of the patient with the tissue-retainingdevice, wherein the joint includes tissue. Step c) includes medicallytreating the retained joint with ultrasound to shrink the tissue usingthe transducer or using the transducer and the ultrasound reflector. Inone implementation, one tissue-retaining member at all times faces alonga direction which is substantially perpendicular to the longitudinalaxis of the end effector (as seen in FIGS. 2 and 4). In one applicationof the third method of the invention, the joint includes connective andnerve tissue.

[0056] As previously mentioned, one application of the ultrasoundmedical treatment system 10 of the previously-described first throughfourth expressions of the first embodiment uses the tissue-retainingdevice to retain a blood vessel and uses the transducer, or thetransducer and the ultrasound reflector, to substantially stop the flowof blood within the blood vessel.

[0057] Referring again to the drawings, FIGS. 7-8 illustrate a secondembodiment of the present invention which is an ultrasound medicaltreatment system 50 including an end effector 52 insertable into apatient. The end effector 52 includes a tissue-retaining device 54. Thetissue-retaining device 54 includes a first tissue-retaining member 56having an ultrasound imaging and medical-treatment transducer 58 andincludes a second tissue-retaining member 60 having an ultrasoundreflector 62. The first and second tissue-retaining members 56 and 60are operatively connected together to retain patient tissue between thefirst and second tissue-restraining members and to release patienttissue so retained. The first and second tissue-retaining members 56 and60 always maintain a substantially parallel alignment.

[0058] Advantages of having a substantially parallel alignment betweenthe tissue-retaining members include, in one example, having thetransducer and the ultrasound reflector maintain a substantiallyparallel alignment for improved reflected ultrasound medical treatmentenhancement for any thickness of patient tissue retained by thetissue-retaining members.

[0059] In one example of the second embodiment, the firsttissue-retaining member 56 is a distal end portion 64 of a first tube66. The ultrasound medical treatment system 50 also includes a secondtube 68, first and second link members 70 and 72, and a cable 74. Thesecond tube 68 is oriented substantially parallel to the first tube 66.The first and second link members 70 and 72 are pivotally attached tothe second tissue-retaining member 60 and to the second tube 68 at pivotpoints 76-82 creating a hinged parallelogram defined by a proximalportion 84 of the second tissue-retaining member 60, a distal portion 86of the second tube 68, and the first and second link members 70 and 72.The ultrasound reflector 62 is disposed at a distal portion 88 of thesecond tissue-retaining member 60 and faces the transducer 58. The cable74 is operatively connected to the hinged parallelogram to move thesecond tissue-retaining member 60 toward and away from the firsttissue-retaining member 56.

[0060] In one variation, the ultrasound medical treatment system 50 alsoincludes an outer tube 90. The cable 74 and the first and second tubes66 and 68 are disposed in the outer tube 90. In one modification, theultrasound medical treatment system 50 also includes a handpiece 92. Thecable 74 and the first, second, and outer tubes 66, 68 and 90 areoperatively connected to the handpiece 92. In one design, theorientation of the first tube 66 about the longitudinal axis of thefirst tube 66 is controlled by a step motor (not shown) disposed in, andactuated by, the handpiece 92. In the same or another design, the firsttube 66 is a hollow tube allowing for transducer wiring (not shown), andthe second tube is a solid tube (not shown). Depending on use, the tubes66, 68, and 90 may be rigid or flexible which also is true for any tubearrangement (specifically disclosed as rigid or flexible, or not sospecifically disclosed) of any end effector and for any end effectoritself of any of the previous or following embodiments of the invention.

Ultrasound Medical Treatment Using Specific Transducer Arrangements

[0061] Deployable Ultrasound Medical Transducers

[0062] Referring to the drawings, FIGS. 9-11 illustrate a thirdembodiment of the present invention. A first expression of the thirdembodiment of the present invention is for an ultrasound medical system94 including a tube 96 and a plurality of resiliently flexible fingers98. The tube 96 has a distal end 100 insertable into a patient and has alumen 102 with a distal opening 104. The fingers 98 are extendable outof the distal opening 104 of the lumen 102 creating a deployed state(seen in FIG. 10) and which are at-least-partially retractable into thedistal opening 104 of the lumen 102 creating a stowed state (seen inFIG. 11). Each finger 98 includes an ultrasound transducer 106. Thedistance between the ultrasound transducers 106 of adjacent fingers 98is greater in the deployed state than in the stowed state. It is notedthat an ultrasound medical system is a medical system which at leastprovides ultrasound imaging or ultrasound medical treatment of apatient.

[0063] Advantages of the tube and extendable/retractable flexible-fingerarray arrangement include, when the transducers are ultrasoundmedical-treatment transducers having a common focal zone in the deployedstate, providing faster medical treatment times by allowing for moretransducer ultrasound-emitting surface area which can be simply stowedinto a compact shape for transport within a patient to and from the siteof patient tissue receiving ultrasound medical treatment.

[0064] In one variation, the fingers 98 are only partially retractedinto the distal opening 104 of the lumen 102 in the stowed state (asseen in FIG. 11). In another variation, not shown, the fingers 98 arecompletely retracted into the distal opening 104 of the lumen 102 in thestowed state. By the fingers 98 being extendable out of the distalopening 104 of the lumen 102 creating the deployed state and beingat-least-partially retractable into the distal opening 104 of the lumen102 creating the stowed state means the fingers 98 protrude more out ofthe distal opening 104 of the lumen 102 in the extended state than (ifat all) in the stowed state. Mechanisms, not shown, for remotelyextending and retracting fingers in a tube include, without limitation,a common shaft attached to the proximal ends of the fingers, disposed inthe lumen of the tube, and spring-biased to move forward upon squeezingof a handpiece and to return backward upon relaxing of the handpiece, asis within the ordinary level of skill of the artisan. In onemodification, the distal opening 104 of the lumen 102 coincides with thedistal end 100 of the tube 96. In another modification, not shown, thedistal opening of the lumen is spaced apart from the distal end of thetube. In one implementation, the distal opening 104 of the lumen 102faces in the same direction as the distal end 100 of the tube 96. Otherimplementations are left to the artisan, such as, without limitation,the distal opening of the lumen facing perpendicular to the distal endof the tube. In one example, at least one of the transducers 106 is anultrasound imaging transducer. In the same or a different example, atleast one of the transducers 106 is an ultrasound medical-treatmenttransducer. In the same or a different example, at least one of thetransducers 106 is an ultrasound imaging and medical-treatmenttransducer.

[0065] A second expression of the third embodiment is for an ultrasoundmedical treatment system 108 including a tube 96 and including an endeffector 110 having a plurality of fingers 98. The tube 96 has a distalend 100 insertable into a patient and has a lumen 102 with a distalopening 104. The fingers 98 are extendable out of the distal opening 104of the lumen 102 creating a deployed state (seen in FIG. 10) and areat-least-partially retractable into the distal opening 104 of the lumen102 creating a stowed state (seen in FIG. 11). Each finger 98 includesan ultrasound medical-treatment transducer 112. The distance between theultrasound medical-treatment transducers 112 of adjacent fingers 98 isgreater in the deployed state than in the stowed state.

[0066] A third expression of the third embodiment is for an ultrasoundmedical treatment system 108 including a tube 96 and including an endeffector 110 having a plurality of fingers 98. The tube 96 has a distalend 100 insertable into a patient and has a lumen 102 with a distalopening 104. The fingers 98 are extendable out of the distal opening 104of the lumen 102 creating a deployed state (seen in FIG. 10) and areat-least-partially retractable into the distal opening 104 of the lumen102 creating a stowed state (seen in FIG. 11). Each finger 98 includesan ultrasound imaging and medical-treatment transducer 114. The distancebetween the ultrasound imaging and medical-treatment transducers 114 ofadjacent fingers 98 is greater in the deployed state than in the stowedstate.

[0067] It is noted that the variations, modifications, andimplementations, etc. previously discussed for the first expression ofthe third embodiment are equally applicable to the second and thirdexpressions of the third embodiment.

[0068] In one example of the first, second and third expressions of thethird embodiment, the transducers 106, 112 and 114 each have anultrasound-emitting concave surface 116. In another example, not shown,the transducers have a planar ultrasound-emitting surface. In onearrangement, each concave surface 116 is concave as one moves along thecorresponding finger 98 (as best seen in FIG. 10). In anotherarrangement, not shown, each concave surface is concave as one movesacross the corresponding finger or is concave as one moves both alongand across the corresponding finger (such as, for example, with ahemispherically-concave surface). In one design, the concave surfaces116 together have a substantially common focal zone when the fingers 98are in the deployed state. The end effector 110 is seen with its fingers98 facing the patient tissue 119 in FIG. 10. In another design, notshown, the focal zones are not common. In one configuration, the fingers98 define an open-hand finger array 118 in the deployed state. Analternate flexible finger arrangement in the form of a substitute endeffector 120 is shown in FIG. 12, wherein the fingers 122 define aclawed-hand finger array 124 in the deployed state. The substitute endeffector 120 is seen with its fingers 122 surrounding the patient tissue126 for imaging and/or medical treatment by the ultrasound transducers128 in FIG. 12. In other transducer arrangements, not shown, one or moreor all of the ultrasound transducers face outward rather than facinginward.

[0069] In the same or another example of the first, second and thirdexpressions of the third embodiment, the fingers 98 are at least four innumber. In the same or yet another example of the second and thirdexpressions of the third embodiment, the end effector 110 (as well asthe substitute end effector 120) is an open-surgery end effector, anendoscopic end effector, a laparoscopic end effector (as shown in FIG.9), a catheter end effector (such as, but not limited to, anintravascular catheter end effector), or a needle end effector, as canbe appreciated by those skilled in the art.

[0070] In one enablement, as shown in FIG. 9, the ultrasound medicaltreatment system 108 also includes a handpiece 130 operatively connectedto the end effector 110 and to an ultrasound controller 132 operativelyconnected to a foot-pedal power switch 133, as can be appreciated bythose skilled in the art.

[0071] Faceted Ultrasound Medical Transducer Assembly

[0072] A fourth embodiment of the present invention is shown in FIGS.13-15. A first expression of the fourth embodiment of the presentinvention is for an ultrasound medical system 134 including anultrasound transducer assembly 136 insertable into a patient. Theultrasound transducer assembly 136 has a longitudinal axis 138. Theultrasound transducer assembly 136 includes a plurality P of ultrasoundtransducers 140. Each transducer 140 has an ultrasound-emitting surface142 oriented at an angle of substantially 360/P degrees apart from theultrasound-emitting surface 142 of an adjacent transducer 140 whenviewed in a cross section (see FIG. 15) of the transducer assembly 136taken by a cutting plane which is perpendicular to the longitudinal axis138.

[0073] Advantages of such a transducer configuration include, in oneexample, providing directed or focused medical-treatment ultrasoundwhich is not possible with a cylindrical ultrasound transducer, as canbe appreciated by those skilled in the art.

[0074] It is noted that an ultrasound transducer assembly 136 insertableinto a patient is an ultrasound imaging transducer assembly, anultrasound medical-treatment transducer assembly, or an ultrasoundimaging and medical-treatment transducer assembly. An ultrasound imagingtransducer assembly has at least one ultrasound imaging transducer, andan ultrasound medical-treatment transducer assembly has at least oneultrasound medical-treatment transducer. An ultrasound imaging andmedical-treatment transducer assembly has at least one ultrasoundimaging transducer and at least one ultrasound medical-treatmenttransducer or has at least one ultrasound imaging and medical-treatmenttransducer.

[0075] A second expression of the fourth embodiment of the presentinvention is for an ultrasound medical-treatment system 144 including anend effector 146 insertable into a patient. The end effector 146includes an ultrasound medical-treatment transducer assembly 148. Theultrasound medical-treatment transducer assembly 148 has a longitudinalaxis 138. The ultrasound medical-treatment transducer assembly 148includes a plurality P of ultrasound medical-treatment transducers 150.Each transducer 150 has an ultrasound-emitting surface 142 which facesaway from the longitudinal axis 138 and which is oriented at an angle ofsubstantially 360/P degrees apart from the ultrasound-emitting surface142 of an adjacent transducer 150 when viewed in a cross section (seeFIG. 15) of the transducer assembly 148 taken by a cutting plane whichis perpendicular to the longitudinal axis 138. In one example, at leastone of the ultrasound medical-treatment transducers 150 is also adaptedfor ultrasound imaging.

[0076] A fourth method of the present invention is for ultrasoundmedical treatment of a patient and uses the ultrasound medical treatmentsystem 144 as previously described in the second expression of thefourth embodiment. The fourth method includes steps a) through b). Stepa) includes inserting the end effector 146 into the liver of thepatient. Step b) includes medically treating a lesion in the liver withultrasound from the ultrasound medical-treatment transducer assembly148. In one example, step a) interstially inserts the end effector 146into the lesion. In another example, step a) endoscopically inserts theend effector 146 into the liver through the hepato-biliary duct system.

[0077] A third expression of the fourth embodiment of the presentinvention is for an ultrasound medical treatment system 144 including anend effector 146 insertable into a patient. The end effector 146includes an ultrasound imaging and medical-treatment transducer assembly152. The ultrasound imaging and medical-treatment transducer assembly152 has a longitudinal axis 138. The ultrasound imaging andmedical-treatment transducer assembly 152 includes a plurality P ofultrasound imaging and medical-treatment transducers 154. Eachtransducer 154 has an ultrasound-emitting surface 142 which faces awayfrom the longitudinal axis 138 and which is oriented at an angle ofsubstantially 360/P degrees apart from the ultrasound-emitting surface142 of an adjacent transducer 154 when viewed in a cross section (seeFIG. 15) of the transducer assembly 152 taken by a cutting plane whichis perpendicular to the longitudinal axis 138.

[0078] A fifth method of the present invention is for ultrasound medicaltreatment of a patient and uses the ultrasound medical-treatment system144 as previously described in the third expression of the fourthembodiment. The fourth method includes steps a) through c). Step a)includes inserting the end effector 146 into the liver of the patient.Step b) includes identifying a lesion in the liver for medical treatmentat least in part from ultrasound imaging using the ultrasound imagingand medical-treatment transducer assembly 152. Step c) includesmedically treating the lesion with ultrasound from the ultrasoundimaging and medical-treatment transducer assembly 152. In one example,step a) interstially inserts the end effector 146 into the lesion. Inanother example, step a) endoscopically inserts the end effector 146into the liver through the hepato-biliary duct system.

[0079] In one example of the previously-described first, second andthird expressions of the fourth embodiment, the transducer assembly 136,148, and 152 has a distal tip 156 and has a tip transducer 158. In onedesign, the tip transducer is a forward facing tip transducer. Inanother design, the tip transducer is a sideways facing tip transducer.In one variation, the tip transducer is an ultrasound imaging tiptransducer. In another variation, the tip transducer is an ultrasoundmedical-treatment tip transducer. In a further variation, the tiptransducer is an ultrasound imaging and medical-treatment tiptransducer. In an additional variation, the tip transducer is atransponder which emits electromagnetic waves or mechanical waves orboth.

[0080] In the same or a different example of the previously-describedfirst, second and third expressions of the third embodiment, eachultrasound-emitting surface 142 is substantially straight when viewed inthe cross section, as seen in FIG. 15. In one variation, as seen in FIG.14, each ultrasound-emitting surface 142 has a substantially concaveshape as one moves along the ultrasound-emitting surface 142 in adirection parallel to the longitudinal axis 138, and eachultrasound-emitting surface 142 has a focal zone. In a first alternatetransducer arrangement seen FIG. 16, each ultrasound-emitting surface162 has a substantially planar shape. In a second alternate transducerarrangement seen in FIG. 17, each ultrasound-emitting surface 164 has asubstantially concave shape when viewed in the cross section, and eachultrasound-emitting surface 164 has a focal zone. In one modification,each ultrasound-emitting surface 164 also has a substantially concaveshape as one moves along the ultrasound-emitting surface 164 in adirection parallel to the longitudinal axis (such as, for example, bythe ultrasound-emitting surface 164 having a hemispherically-concaveshape). Such ultrasound-emitting surface shapes are equally applicableto any ultrasound transducer mentioned in any other embodiment of theinvention.

[0081] In the same or a different example of the previously-describedfirst, second and third expressions of the third embodiment, P is nogreater than four. In one variation, P equals three as seen in FIGS. 15and 17. In another variation, P equals two as seen in FIG. 16.

[0082] In the same or a different example of the previously-describedsecond and third expressions of the third embodiment, the end effector146 is an open-surgery end effector, an endoscopic end effector, alaparoscopic end effector (as shown in FIG. 13), a catheter end effector(such as, but not limited to, an intravascular catheter end effector),or a needle end effector, as can be appreciated by those skilled in theart. In one enablement, as shown in FIG. 13, the ultrasound medicaltreatment system 144 also includes a handpiece 166 operatively connectedto the end effector 146 and to an ultrasound controller 168 operativelyconnected to a foot-pedal power switch 169, as can be appreciated by theartisan.

Ultrasound Medical Treatment Applications

[0083] Excisional and Ultrasound Medical Treatment System

[0084] A fifth embodiment of the present invention is shown in FIGS.18-20. In a first expression of the fifth embodiment of the presentinvention, an ultrasound medical treatment system 170 includes a tube172, a first end effector 174, and a second end effector 176. The tube172 has a distal end 178 insertable into a patient 180 and has a lumen182. The first end effector 174 has a cutting tool 184, is introducibleinto the lumen 182 of the inserted tube 172 from outside the patient180, and is translatable through the lumen 182 of the inserted tube 172to inside the patient 180. The second end effector 176 has an ultrasoundmedical-treatment transducer assembly 186, is introducible into thelumen 182 of the inserted tube 172 from outside the patient 180, and istranslatable through the lumen 182 of the inserted tube 172 to insidethe patient 180. In one variation, the first and second end effectorsare introduced into the lumen through separate openings in the lumen orthrough separate branch channels leading to the lumen. In anothervariation, the first and second end effectors are introduced into thelumen through the same opening in the lumen. In one modification, alumen opening is disposed at the end of the tube. In anothermodification, a lumen opening is spaced apart from the end of the tube.

[0085] A second expression of the fifth embodiment of the presentinvention is for an ultrasound medical treatment system 170 including atube 172, a first end effector 174, and a second end effector 176. Thetube has a distal end 178 insertable into a patient 180 and has a lumen182 with a distal opening 188 and a proximal opening 190. The first endeffector 174 has a cutting tool 184, is introducible into the proximalopening 190, and is translatable through the lumen 182 to the distalopening 188. The second end effector 176 has an ultrasoundmedical-treatment transducer assembly 186, is introducible into theproximal opening 190, and is translatable through the lumen 182 to thedistal opening 188.

[0086] In one example of the first and second expressions of the fifthembodiment of the present invention, the lumen 182 is sized to allowintroduction of only one of the first and second end effectors 174 and176 at a time. In the same or another example, the distal end 178 of thetube 172 is interstitially insertable into patient tissue 192 of thepatient 180. In the same or a different example, the cutting tool 184 isa biopsy cutting tool 194 or other excisional cutting tool.

[0087] A third expression of the fifth embodiment of the presentinvention is for an ultrasound medical treatment system 170 including atube 172, a first end effector 174, and a second end effector 176. Thetube 172 has a distal end 178 interstitially insertable into breasttissue 196 of a patient 180 and has a lumen 182 with a distal opening188 and a proximal opening 190. The first end effector 174 has a biopsycutting tool 194 (or other excisional cutting tool), is introducibleinto the proximal opening 190, and is translatable through the lumen 182to the distal opening 188. The second end effector 176 has an ultrasoundmedical-treatment transducer assembly 186, is introducible into theproximal opening 190, and is translatable through the lumen 182 to thedistal opening 188. The lumen 182 is sized to allow introduction of onlyone of the first and second end effectors 174 and 176 at a time. In onedesign, the first end effector also includes a suction mechanism to drawin patient tissue to be biopsied by the biopsy cutting tool 194. In oneapplication, the tube 172 and the first end effector 174 (with thebiopsy cutting tool 194 including a suction mechanism) are based oncomponents of a Mammotome® Breast Biopsy System manufactured by EthiconEndo-Surgery, Inc. (a Johnson & Johnson Company).

[0088] A sixth method of the invention is for ultrasound medicaltreatment of a patient 180 and uses the ultrasound medical treatmentsystem 170 as previously described in the third expression of the fifthembodiment of the present invention. The sixth method includes steps a)through h). Step a) includes identifying possibly cancerous breasttissue 196 of the patient. Step b) includes interstitially inserting thedistal end 178 of the tube 172 into the patient 180 with the distalopening 188 disposed proximate the breast tissue 196 and with theproximal opening 190 disposed outside the patient. Step c) includesintroducing the first end effector 174 into the proximal opening 190 andtranslating the first end effector 174 through the lumen 182 to thedistal opening 188. Step d) includes obtaining a biopsy sample of thebreast tissue 196 with the biopsy cutting tool 194. Step e) includesremoving the first end effector 174 from the lumen 182, Step f) includesintroducing the second end effector 176 into the proximal opening 190and translating the second end effector 176 through the lumen 182 to thedistal opening 188. Step g) includes identifying an area of hemorrhagingin the breast tissue where the biopsy sample was obtained. Step h)includes medically treating the identified area with ultrasound usingthe transducer assembly 186 to substantially stop the hemorrhaging. Inone application, the sixth method of the invention also includes thesteps of testing the biopsy sample for cancer and substantially ablatingany remaining cancer in the breast tissue with ultrasound using thetransducer assembly 186. Advantages of such an ultrasound medicaltreatment system and method include the ease of obtaining a breastbiopsy and the control of hemorrhaging caused by the biopsy procedurecoupled together in a minimally invasive manner.

[0089] In a fourth expression of the fifth embodiment of the presentinvention, an ultrasound medical treatment system 170 includes a tube172, a first end effector 174, and a second end effector 176. The tube172 has a distal end 178 insertable into a patient 180 and has a lumen182. The first end effector 174 has a cutting tool 184, is introducibleinto the lumen 182 of the inserted tube 172 from outside the patient180, and is translatable through the lumen 182 of the inserted tube 172to inside the patient 180. The second end effector 176 has an ultrasoundimaging and medical-treatment transducer assembly 198, is introducibleinto the lumen 182 of the inserted tube 172 from outside the patient180, and is translatable through the lumen 182 of the inserted tube 172to inside the patient 180. In one variation, the first and second endeffectors are introduced into the lumen through separate openings in thelumen or through separate branch channels leading to the lumen. Inanother variation, the first and second end effectors are introducedinto the lumen through the same opening in the lumen. In onemodification, a lumen opening is disposed at the end of the tube. Inanother modification, a lumen opening is spaced apart from the end ofthe tube.

[0090] A fifth expression of the fifth embodiment of the presentinvention is for an ultrasound medical treatment system 170 including atube 172, a first end effector 174, and a second end effector 176. Thetube has a distal end 178 insertable into a patient 180 and has a lumen182 with a distal opening 188 and a proximal opening 190. The first endeffector 174 has a cutting tool 184, is introducible into the proximalopening 190, and is translatable through the lumen 182 to the distalopening 188. The second end effector 176 has an ultrasound imaging andmedical-treatment transducer assembly 198, is introducible into proximalopening 190, and is translatable through the lumen 182 to the distalopening 188.

[0091] In one example of the fourth and fifth expressions of the fifthembodiment of the present invention, the lumen 182 is sized to allowintroduction of only one of the first and second end effectors 174 and176 at a time. In the same or another example, the distal end 178 of thetube 172 is interstitially insertable into patient tissue 192 of thepatient 180. In the same or a different example, the cutting tool 184 isa biopsy cutting tool 194 or other excisional cutting tool.

[0092] A sixth expression of the fifth embodiment of the presentinvention is for an ultrasound medical treatment system 170 including atube 172, a first end effector 174, and a second end effector 176. Thetube 172 has a distal end 178 interstitially insertable into breasttissue 196 of a patient 180 and has a lumen 182 with a distal opening188 and a proximal opening 190. The first end effector 174 has a biopsycutting tool 194 (or other excisional cutting tool), is introducibleinto the proximal opening 190, and is translatable through the lumen 182to the distal opening 188. The second end effector 176 has an ultrasoundimaging and medical-treatment transducer assembly 196, is introducibleinto the proximal opening 190, and is translatable through the lumen 182to the distal opening 188. The lumen 182 is sized to allow introductionof only one of the first and second end effectors 174 and 176 at a time.In one application, the tube 172 and the first end effector 174 (withthe biopsy cutting tool 194 including a suction mechanism) are based oncomponents of a Mammotome® Breast Biopsy System manufactured by EthiconEndo-Surgery, Inc. (a Johnson & Johnson Company).

[0093] A seventh method of the invention is for ultrasound medicaltreatment of a patient 180 and uses the ultrasound medical treatmentsystem 170 as previously described in the sixth expression of the fifthembodiment of the present invention. The seventh method includes stepsa) through h). Step a) includes identifying possibly cancerous breasttissue 196 of the patient. Step b) includes interstitially inserting thedistal end 178 of the tube 172 into the patient 180 with the distalopening 188 disposed proximate the breast tissue 196 and with theproximal opening 190 disposed outside the patient. Step c) includesintroducing the first end effector 174 into the proximal opening 190 andtranslating the first end effector 174 through the lumen 182 to thedistal opening 188. Step d) includes obtaining a biopsy sample of thebreast tissue 196 with the biopsy cutting tool 194. Step e) includesremoving the first end effector 174 from the lumen 182, Step f) includesintroducing the second end effector 176 into the proximal opening 190and translating the second end effector 176 through the lumen 182 to thedistal opening 188. Step g) includes identifying an area of hemorrhagingin the breast tissue where the biopsy sample was obtained fromultrasound imaging using the transducer assembly 198. Step h) includesmedically treating the identified area with ultrasound using thetransducer assembly 198 to substantially stop the hemorrhaging. In oneapplication, the seventh method of the invention also includes the stepsof testing the biopsy sample for cancer and substantially ablating anyremaining cancer in the breast tissue with ultrasound using thetransducer assembly 198. Advantages of such an ultrasound medicaltreatment system and method include the ease of obtaining a breastbiopsy and the imaging and control of hemorrhaging caused by the biopsyprocedure coupled together in a minimally invasive manner.

[0094] In one enablement, as shown in FIG. 18, the ultrasound medicaltreatment system 170 also includes a handpiece 199 which is attached tothe tube 172, which contains the first end effector 174 for extendingthe cutting tool 184 into, and withdrawing it from, the lumen 182, andwhich is operatively connected to an ultrasound controller 201 via afirst cable 203. The second end effector 176, in this enablement, isoperatively connected to the ultrasound controller 201 via a secondcable 205 and is inserted into the lumen 182 from outside the handpiece199 as shown in FIG. 18.

[0095] Staging Medical Treatment Using Ultrasound

[0096] An eighth method of the invention is shown in block diagram formin FIG. 21 and is for medical treatment of a patient. The eighth methodincludes steps a) through f). Step a) is labeled “Obtain TransducerAssembly” in block 200 of FIG. 21. Step a) includes obtaining anultrasound imaging transducer assembly. Step b) is labeled “InsertAssembly Into Gastrointestinal Area” in block 202 of FIG. 21. Step b)includes inserting the transducer assembly into a gastrointestinal areaof the patient. Step c) is labeled “Guide Assembly” in block 204 of FIG.21. Step c) includes guiding the transducer assembly within thegastrointestinal area. Step d) is labeled “Identify Patient Tissue ForTreatment” in block 206 of FIG. 21. Step d) includes identifying patienttissue in the gastrointestinal area for medical treatment. Step e) islabeled “Stage Treatment From Ultrasound Imaging” in block 208 of FIG.21. Step e) includes staging the medical treatment from ultrasoundimaging using the transducer assembly. Step f) is labeled as “MedicallyTreat Patient” in block 210 of FIG. 21. Step f) includes medicallytreating the patient tissue according to the staging of step e). It ispointed out that in the eighth method the medical treatment need notinclude ultrasound medical treatment with the transducer assembly usedfor staging and/or need not include ultrasound medical treatment withany other ultrasound transducer assembly. In one procedure depending onthe pathology size and site, a first transducer assembly is usedendoscopically to stage the medical treatment in step e) and a secondtransducer assembly is used laparoscopically to medically treat thepatient tissue with ultrasound in step f). In one variation, the firsttransducer assembly is used laparoscopically to stage the medicaltreatment in step e) and the second transducer assembly is usedendoscopically to medically treat the patient tissue with ultrasound instep f). In another procedure, the medical treatment in step f) isradio-frequency, laser, microwave, or chemical ablation medicaltreatment. Other types of medical treatment are left to the artisan.

[0097] It is noted that the gastrointestinal (GI) area of a humanpatient includes, without limitation, the esophagus and the stomach ofthe upper GI area and the rectum and the colon of the lower GI area. Itfurther is noted that the liver is also considered to be in the GI areafor purposes of this method.

[0098] By “staging the medical treatment from ultrasound imaging” ismeant at least using ultrasound images to determine thethree-dimensional size and shape of the patient tissue that is toreceive medical treatment. For example, and without limitation, upperand lower GI tumors can be visualized with high frequency (6-30 MHz)ultrasound imaging using a cylindrical, side-firing, or half-convexultrasound array or single-element transducer introduced endoscopicallyinto the GI tract. All layers of the GI tract can be visualizedincluding all layers of the esophagus, stomach, duodenum, colon, etc. Inone procedure, a three-dimensional representation of the GI structuresis created by collating a series of two-dimensional scans generated byaxially advancing the ultrasound transducer. Any neoplastic growth, itsmorphological characteristics, as well as the tumor's size and shape caneasily be determined from the three-dimensional representation.

[0099] Advantages of such medical-treatment staging from ultrasoundimaging include, in one example, providing a non-invasivemedical-treatment staging technique which has greater resolution andwhich is more practical compared to conventional extracorporealmedical-treatment staging techniques such as using x-rays or MRI imagingor compared to using conventional endoscopic optical techniques.

[0100] A ninth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through f). The ninthmethod uses the same block diagram of FIG. 21 as does the eighth methodbut with “end effector” replacing “transducer assembly” in block 200 andwith “end effector” replacing “assembly” in blocks 202 and 204. Step a)includes obtaining an end effector having an ultrasound imaging andmedical-treatment transducer assembly. Step b) includes inserting theend effector into a gastrointestinal area of the patient. Step c)includes guiding the transducer assembly within the gastrointestinalarea. Step d) includes identifying patient tissue in thegastrointestinal area for medical treatment. Step e) includes stagingthe medical treatment from ultrasound imaging using the transducerassembly. Step f) includes medically treating the patient tissue withultrasound using the transducer assembly according to the staging ofstep e).

[0101] A tenth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through f). The tenthmethod uses the same block diagram of FIG. 21 as does the eighth methodbut with “end effector” replacing “transducer assembly” in block 200 andwith “end effector” replacing “assembly” in blocks 202 and 204. Step a)includes obtaining an end effector having an ultrasound imaging andmedical-treatment transducer assembly. Step b) includes inserting theend effector into a gastrointestinal area of the patient. Step c)includes guiding the transducer assembly within the gastrointestinalarea. Step d) includes identifying patient tissue in thegastrointestinal area for medical treatment at least in part fromultrasound imaging using the transducer assembly. Step e) includesstaging the medical treatment from ultrasound imaging using thetransducer assembly. Step f) includes medically treating the patienttissue with ultrasound using the transducer assembly according to thestaging of step e). In one procedure, large GI tumors are staged througha laparoscopic access to the GI area, whereby the tumors are identified,staged and treated using an end effector having an ultrasound imagingand medical-treatment transducer assembly.

[0102] In one example of the ninth and tenth methods of the invention,the patient tissue is gastroesophageal tissue containing a lesion, andstep f) ultrasonically substantially ablates the lesion. In onemodification, the gastroesophageal tissue contains a blood vesselsupplying blood to the lesion, and step f) ultrasonically treats theblood vessel to substantially stop the supply of blood to the lesionfrom the blood vessel.

[0103] In another example of the ninth and tenth methods of theinvention, the patient tissue is liver tissue containing a lesion and ablood vessel supplying blood to the lesion, and step f) ultrasonicallytreats the blood vessel to substantially stop the supply of blood to thelesion from the blood vessel.

[0104] In an additional example of the ninth and tenth methods of theinvention, the patient tissue is liver tissue containing a lesion, andstep f) ultrasonically substantially ablates the lesion. In onemodification, the liver tissue contains a blood vessel supplying bloodto the lesion, and step f) also ultrasonically treats the blood vesselto substantially stop the supply of blood to the lesion from the bloodvessel. In one procedure, an end effector having an ultrasound imagingand medical-treatment transducer assembly is introduced endoscopicallyinto the GI tract, is advanced retrogradely through the ampulla of Vaterup the common bile duct, and is advanced further into the hepatic ductsystem where liver parenchyma requiring medical treatment (such ascholangio-carcinomas) are identified, staged, and treated using the endeffector.

[0105] Treatment of Lung Lesions Using Ultrasound

[0106] An eleventh method of the invention is shown in block diagramform in FIG. 22 and is for ultrasound medical treatment of a patient.The eleventh method includes steps a) through f). Step a) is labeled“Obtain End Effector” in block 212 of FIG. 22. Step a) includesobtaining an end effector having an ultrasound medical-treatmenttransducer assembly. Step b) is labeled “Insert End Effector” in block214 of FIG. 22. Step b) includes inserting the end effector into thepatient. Step c) is labeled “Guide End Effector To Lung” in block 216 ofFIG. 22. Step c) includes guiding the end effector within the patient toa lung of the patient. Step d) is labeled “Identify Lesion” in block 218of FIG. 22. Step d) includes identifying a lesion on or in the lung formedical treatment. Step e) is labeled “Position Transducer Assembly” inblock 220 of FIG. 22. Step e) includes positioning the transducerassembly on or in the lesion. Step f) is labeled “Medically TreatLesion” in block 222 of FIG. 22. Step f) includes medically treating thelesion with ultrasound using the transducer assembly.

[0107] A twelfth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through f). The twelfthmethod uses the same block diagram of FIG. 22 as does the eleventhmethod. Step a) includes obtaining an end effector having an ultrasoundimaging and medical-treatment transducer assembly. Step b) includesinserting the end effector into the patient. Step c) includes guidingthe end effector within the patient to a lung of the patient. Step d)includes identifying a lesion on or in the lung for medical treatment atleast in part from ultrasound imaging using the transducer assembly.Step e) includes positioning the transducer assembly on or in thelesion. Step f) includes medically treating the lesion with ultrasoundusing the transducer assembly.

[0108] In one example of the eleventh and twelfth methods, step f)ultrasonically substantially ablates the lesion. In one application, theend effector is an endoscopic end effector and step b)transbronchial-endoscopically inserts the end effector into the patient.In another application, the end effector is a needle end effector andstep b) interstitially inserts the end effector into the patient. In oneimplementation, step e) positions the transducer assembly on the lesion.In another implementation, step e) positions the transducer assembly inthe lesion. In one practice of the eleventh and twelfth methods, step c)a bronchoscope is used to guide the end effector to a lung of thepatient.

[0109] Ultrasound medical treatment of the lung has conventionally beenavoided because such ultrasound is prevented from reaching a lesionwithin the lung by the alveoli of the lung which contain air whichreflect back most of the ultrasound preventing the ultrasound fromeffectively penetrating the lung to the lesion. Using higher powerultrasound for effective penetration of the lung to reach the lesionwould injure or destroy the alveoli which are needed for breathing.Applicants theorized that positioning the ultrasound transducer on or ina lesion of the lung would allow ultrasound medical treatment of thelesion (such as a tumor or an infarct) without injury to the alveoli. Itis noted that Applicants' method is applicable to surface lesions aswell as non-surface lesions. Advantages of Applicants' eleventh andtwelfth methods for ultrasound medical treatment include, in oneexample, the destruction of lung cancer lesions in cases which otherwisewould be inoperable or incurable.

[0110] Ultrasound-Based Occlusive Procedure for Medical Treatment

[0111] A thirteenth method of the invention is shown in block diagramform in FIG. 23 and is for ultrasound medical treatment of a patient.The thirteenth method includes steps a) through e). Step a) is labeled“Obtain End Effector” in block 224 of FIG. 23. Step a) includesobtaining an end effector having an ultrasound medical-treatmenttransducer assembly. Step b) is labeled “Insert End Effector” in block226 of FIG. 23. Step b) includes inserting the end effector into thepatient. Step c) is labeled “Guide End Effector” in block 228 of FIG.23. Step c) includes guiding the end effector within the patient to aregion of patient tissue containing a lesion. Step d) is labeled“Identify Blood Vessel Supplying Lesion” in block 230 of FIG. 23. Stepd) includes identifying a blood vessel in the region which suppliesblood to the lesion. Step e) is labeled “Stop Blood Supply UsingUltrasound” in block 232 of FIG. 23. Step e) includes medically treatingthe blood vessel with ultrasound from the transducer assembly tosubstantially seal the blood vessel to stop the supply of blood to thelesion from the blood vessel. One implementation of the thirteenthmethod of the invention also includes the step of medically treating thelesion with ultrasound from the transducer assembly to substantiallyablate the lesion.

[0112] A fourteenth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through g). The fourteenthmethod is similar to the thirteenth method. Step a) includes obtainingan end effector having an ultrasound imaging and medical-treatmenttransducer assembly. Step b) includes inserting the end effector intothe patient. Step c) includes guiding the end effector within thepatient to a region of patient tissue containing a lesion. Step d)includes identifying the lesion at least in part from ultrasound imagingusing the transducer assembly. Step e) includes identifying a bloodvessel in the region which supplies blood to the lesion from ultrasoundimaging using the transducer assembly. Step f) includes medicallytreating the blood vessel with ultrasound from the transducer assemblyto substantially seal the blood vessel to substantially stop the supplyof blood to the lesion from the blood vessel. Step g) includes medicallytreating the lesion with ultrasound from the transducer assembly tosubstantially ablate the lesion. It is noted that Doppler ultrasoundimaging alone, gray-scale ultrasound imaging alone, and a combination ofDoppler and gray-scale ultrasound imaging are known ultrasoundtechniques to image blood flow in blood vessels.

[0113] In one application of the thirteenth and fourteenth methods, theend effector is an open-surgery end effector. In another application,the end effector is an endoscopic end effector. In a furtherapplication, the end effector is a laparoscopic end effector. In anadditional application, the end effector is a catheter end effector(such as, but not limited to, an intravascular catheter end effector).In a different application, the end effector is a needle end effector.

[0114] A broadened thirteenth method of the invention eliminates theinserting into and guiding within steps of the above-describedthirteenth method and includes steps a) through c). Step a) includesobtaining an end effector having an ultrasound medical-treatmenttransducer assembly. Step b) includes identifying a blood vessel in thepatient which supplies blood to a lesion. Step c) includes medicallytreating the blood vessel with ultrasound from the transducer assemblyto substantially seal the blood vessel to substantially stop the supplyof blood to the lesion from the blood vessel.

[0115] A broadened fourteenth method of the invention eliminates theinserting into and guiding within steps of the above-describedfourteenth method and includes steps a) through e). Step a) includesobtaining an end effector having an ultrasound imaging andmedical-treatment transducer assembly. Step b) includes identifying alesion in the patient at least in part from ultrasound imaging using thetransducer assembly. Step c) includes identifying a blood vessel whichsupplies blood to the lesion from ultrasound imaging using thetransducer assembly. Step d) includes medically treating the bloodvessel with ultrasound from the transducer assembly to substantiallyseal the blood vessel to substantially stop the supply of blood to thelesion from the blood vessel. Step e) includes medically treating thelesion with ultrasound from the transducer assembly to substantiallyablate the lesion.

[0116] In one example of the broadened thirteenth and fourteenthmethods, the end effector is an extracorporeal end effector. In anotherexample, the end effector is an intracorporeal end effector. In afurther example, the end effector can be used in both an extracorporealmode and in an intracorporeal mode.

[0117] Advantages of Applicants' thirteenth and broadened thirteenthmethods for ultrasound medical treatment include, in one example, theindirect destruction of cancer lesions by ultrasound hemostasis in bloodvessels supplying the cancer lesions in cases which otherwise would beinoperable or incurable because the location of the cancer lesionsprevents medical treatment of the lesions themselves. Advantages ofApplicants' fourteenth and broadened fourteenth methods for ultrasoundtreatment include, in one example, direct destruction of cancer lesionsby ultrasound ablation of the cancer lesions together with the indirectdestruction of any cancer lesions missed in the ultrasound ablation stepby ultrasound hemostasis in blood vessels supplying blood to the missedcancer lesions.

Guiding and Targeting Ultrasound End Effectors

[0118] Guiding Ultrasound End Effector for Medical Treatment

[0119] A sixth embodiment of the present invention is shown in FIG. 24.In a first expression of the sixth embodiment of the present invention,an ultrasound medical treatment system 234 (only a portion of which isshown in FIG. 24) includes an end effector 236 and at least threereceivers 238. The end effector 236 has a transducer assembly 240including a transducer 242 having at least one transducer element 244adapted for emitting medical-treatment ultrasound waves and for emittingmechanical waves. It is noted that the terminology “mechanical waves”includes ultrasound and non-ultrasound compression (acoustic) waves andultrasound and non-ultrasound shear waves, and that waves include wavepulses. The receivers 238 are spaced apart from the transducer assembly240, and the receivers 238 are adapted to receive the emitted mechanicalwaves for use in locating the position of the transducer assembly 240.Conventional methods (including triangulation methods) for locating theposition of a transponder emitting waves which are received by threereceivers are well known. A second expression of the sixth embodiment isidentical to the first expression of the sixth embodiment except thatthe at-least-one transducer element 244 is also adapted for emittingimaging ultrasound waves. In one variation of the first and secondexpressions of the sixth embodiment, the end effector and the receiversare disposable outside (including in one modification on) the patient.In another variation, the end effector is insertable into the patientand the receivers are disposable outside (including in one modificationon) the patient.

[0120] A seventh embodiment of the present invention is shown in FIG.25. In a first expression of the seventh embodiment of the presentinvention, an ultrasound medical treatment system 246 (only a portion ofwhich is shown in FIG. 25) includes an end effector 248 and at leastthree receivers 250. The end effector 248 has an ultrasoundmedical-treatment transducer assembly 252 and has a transponder 254 Thetransponder 254 is adapted to emit waves, and the waves includeelectromagnetic waves or mechanical waves or both. The receivers 250 arespaced apart from the transducer assembly 252, and the receivers 250 areadapted to receive the emitted waves for use in locating the position ofthe transponder 254. In a second expression of the seventh embodiment,the ultrasound medical-treatment transducer assembly 252 is anultrasound imaging and medical-treatment transducer assembly 256.

[0121] In one application of the first and second expressions of theseventh embodiment, the end effector 248 is insertable into a patient,the transponder 254 is adapted to emit electromagnetic waves, and thereceivers 250 are disposable outside the patient. In one variation, thereceivers 250 are disposable on the patient. In another application, theend effector is disposable outside (including in one modification on)the patient and the receivers are disposable outside (including in onemodification on) the patient.

[0122] In one example of the first and second expressions of the seventhembodiment, the end effector 248 is an endoscopic end effector, alaparoscopic end effector, a catheter end effector (such as, but notlimited to, an intravascular catheter end effector), or a needle endeffector. In one design of the first and second expressions of theseventh embodiment, the end effector 248 has a distal tip 260, and thetransponder 254 is disposed at the distal tip 260 of the end effector248. In one variation, the transducer assembly 252 and 256 is disposedproximate the transponder 254.

[0123] A fifteenth method of the invention uses the ultrasound medicaltreatment system of the first expression of the seventh embodiment andincludes steps a) through h). Step a) includes inserting the endeffector 248 into the patient. Step b) includes disposing the receivers250 outside the patient. Step c) includes emitting electromagnetic wavesfrom the transponder 254. Step d) includes receiving the electromagneticwaves with the disposed receivers 250. Step e) includes calculating theposition of the transponder 254 from the received electromagnetic waves.Step f) includes guiding the end effector within the patient to adesired location from the calculated position of the transponder 254.Step g) includes, after step f), identifying patient tissue for medicaltreatment. Step h) includes medically treating the identified patienttissue with ultrasound using the transducer assembly 252.

[0124] A sixteenth method of the invention uses the ultrasound medicaltreatment system of the second expression of the seventh embodiment andincludes steps a) through h). Step a) includes inserting the endeffector 248 into the patient. Step b) includes disposing the receivers250 outside the patient. Step c) includes emitting electromagnetic wavesfrom the transponder 254. Step d) includes receiving the electromagneticwaves with the disposed receivers 250. Step e) includes calculating theposition of the transponder 254 from the received electromagnetic waves.Step f) includes guiding the end effector within the patient to adesired location from the calculated position of the transponder 254.Step g) includes, after step f), identifying patient tissue for medicaltreatment at least in part from ultrasound imaging using the transducerassembly 256. Step h) includes medically treating the identified patienttissue with ultrasound using the transducer assembly 256.

[0125] A known electromagnetic transponder and three-receiver system forcalculating the position of the transponder and for guiding thetransponder (which is attached to a heart catheter for monitoring theheart) inside a patient is the CARTO™ EP Navigation System used with aNAVI-STAR ® catheter manufactured by Biosense Webster (a Johnson &Johnson Company).

[0126] Advantages of an end effector with ultrasound medical treatmentand position-location capabilities include, in one example, moreaccurately guiding the end effector inside a patient to patient tissuefor ultrasound medical treatment of the patient tissue.

[0127] Method for Aiming Ultrasound for Medical Treatment

[0128] A seventeenth method of the invention is shown in block diagramform in FIG. 26 and is for ultrasound medical treatment of a patient.The seventeenth method includes steps a) through f). Step a) is labeled“Obtain End Effector” in block 262 of FIG. 26. Step a) includesobtaining an end effector having an ultrasound medical-treatmenttransducer assembly. Step b) is labeled “Aim Transducer Assembly” inblock 264 of FIG. 26. Step b) includes aiming the transducer assembly tofocus ultrasound energy at a desired focal zone of patient tissue. It isnoted that, in one example, to aim a transducer assembly means to focusultrasound energy at a particular distance from the transducer assemblyand along a particular direction. Step c) is labeled “ActivateTransducer Assembly” in block 266 of FIG. 26. Step c) includesactivating the aimed transducer assembly to emit ultrasound energysufficient to achieve a temperature increase in the patient tissueessentially without medically affecting the patient tissue. Step d) islabeled “Detect Actual Focal Zone” in block 268 of FIG. 26. Step d)includes after step c) detecting, from reflected ultrasound energy, anactual focal zone of patient tissue having a temperature increase. Stepe) is labeled “Correct For Any Aiming Error” in block 269 of FIG. 26.Step e) includes correcting for any error between the desired focal zoneand the actual focal zone. Step f) is labeled “Medically Treat PatientTissue” in block 270 of FIG. 26. Step f) includes after step e),medically treating the patient tissue with ultrasound using thetransducer assembly. In one application, step d) uses one or moreadditional ultrasound transducer assemblies, separate from theultrasound transducer assembly used in steps a) through c) and e)through f), to detect, from reflected ultrasound energy, the actualfocal zone. In another application, the same ultrasound transducerassembly is used for steps a) through f). In one example of theseventeenth method, the end effector is an extracorporeal end effector.In another example, the end effector is an intracorporeal end effector.In a further example, the end effector can be used in both anextracorporeal mode and in an intracorporeal mode.

[0129] An eighteenth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through f). The eighteenthmethod uses the same block diagram of FIG. 26 as does the seventeenthmethod. Step a) includes obtaining an end effector having an ultrasoundimaging and medical-treatment transducer assembly. Step b) includesaiming the transducer assembly to focus ultrasound energy at a desiredfocal zone of patient tissue. Step c) includes activating the aimedtransducer assembly to emit ultrasound energy sufficient to achieve atemperature increase in the patient tissue essentially without medicallyaffecting the patient tissue. Step d) includes after step c) detecting,from reflected ultrasound energy using the transducer assembly, anactual focal zone of patient tissue having a temperature increase. Stepe) includes correcting for any error between the desired focal zone andthe actual focal zone. Step f) includes after step e), medicallytreating the patient tissue with ultrasound using the transducerassembly. In one example, the end effector is an extracorporeal endeffector. In another example, the end effector is an intracorporeal endeffector. In a further example, the end effector can be used in both anextracorporeal mode and in an intracorporeal mode.

[0130] A nineteenth method of the invention is for ultrasound medicaltreatment of a patient and includes steps a) through i). The nineteenthmethod uses the same block diagram of FIG. 26 as does the seventeenthmethod but with three extra steps added between block 262's step a) andblock 264's step b) of the seventeenth method. In the nineteenth method,step a) includes obtaining an end effector having an ultrasound imagingand medical-treatment transducer assembly. Step b) includes insertingthe end effector into the patient. Step c) includes guiding the endeffector inside the patient. Step d) includes identifying a desiredfocal zone of patient tissue at least in part from ultrasound imagingusing the transducer assembly. Step e) includes aiming the transducerassembly to focus ultrasound energy at the desired focal zone of patienttissue. Step f) includes activating the aimed transducer assembly toemit ultrasound energy sufficient to achieve a temperature increase inthe patient tissue essentially without medically affecting the patienttissue. Step g) includes after step f) detecting, from reflectedultrasound energy using the transducer assembly, an actual focal zone ofpatient tissue having a temperature increase. Step h) includescorrecting for any error between the desired focal zone and the actualfocal zone. Step i) includes after step h), medically treating thepatient tissue with ultrasound using the transducer assembly.

[0131] In one example of the seventeenth through nineteenth methods, theend effector is an endoscopic end effector. In another example, the endeffector is a laparoscopic end effector. In a further example, the endeffector is a catheter end effector (such as, but not limited to, anintravascular catheter end effector). In an additional example, the endeffector is a needle end effector.

[0132] It is noted that the achieved temperature increase will decreaseover time so that the detected temperature increase may not exactlyequal the achieved temperature increase. In one implementation of theseventeenth through nineteenth methods, the temperature increasedetected in the detecting step is equal substantially to the temperatureincrease achieved in the activating step. In one application of theseventeenth through nineteenth methods, the detected temperatureincrease is not greater than about five degrees Celsius. In onevariation, the detected temperature increase is not greater than abouttwo degrees Celsius.

[0133] It is noted that conventional methods are known to the artisan toconvert ultrasound image data into temperature images. In one variationof the seventeenth through nineteenth methods, the correcting step isperformed automatically by a feedback control on the same mechanism usedto aim the transducer assembly in the aiming step, as can be appreciatedby the artisan. As previously noted, mechanisms for aiming an ultrasoundmedical-treatment transducer assembly include conventional electronicand/or mechanical techniques as are known to those skilled in the art.

[0134] Advantages of correcting for any error between the desired andactual focal zones before medical treatment include more preciseultrasound medical treatment of patient tissue. In one example, bettertargeting maximizes the ablation of a lesion (and any appropriatemargin) while minimizing medical treatment of patient tissue outside thelesion (and outside any appropriate margin).

Ultrasound Imaging of Patient Tissue

[0135] Ultrasound Feedback in Medically-Treated Patients

[0136] A twentieth method of the invention is shown in block diagramform in FIG. 27 and is for ultrasound imaging of patient tissue of apatient. The twentieth method includes steps a) through c). Step a) islabeled “Obtain A First Signal From A Location At A First Time” in block272 of FIG. 27. Step a) includes obtaining a first signal of a firstimaging ultrasound wave which has been reflected back from a location inthe patient tissue at a first time. Step b) is labeled “Obtain A SecondSignal From The Location At A Later Second Time” in block 274 of FIG.27. Step b) includes obtaining a second signal of a second imagingultrasound wave which has been reflected back from the location in thepatient tissue at a later second time wherein the patient has receivedat least some medical treatment by the second time. Step c) is labeled“Create An Image Of The Location Using The Two Signals” in block 276 ofFIG. 27. Step c) includes creating an image of the location using thefirst signal and the second signal. It is understood that theterminology “creating an image” includes, without limitation, creatingan image in visual form displayed, for example, on a monitor andcreating an image in electronic form which, for example, is used by acomputer without being displayed in visual form on a monitor. In oneenablement of the twentieth method of the invention, the image of thelocation is visually displayed at a pixel location on a monitor.

[0137] In one example of the twentieth method of the invention, step c)includes creating an image of the location using at least the amplitudeof the first signal and the amplitude of the second signal. In onevariation, step c) calculates the difference in the amplitudes betweenthe first and second signals. In one modification, step c) uses thecalculated amplitude difference and uses one of the amplitudes of one ofthe first and second signals. In one implementation, step c) calculatesthe sum of the one amplitude and a function of the calculated amplitudedifference. In one illustration for a first signal amplitude of 6 and asecond signal amplitude of 7, step c) calculates the amplitudedifference, adds the difference to the second signal amplitude creatinga processed amplitude of 8, and creates the image of the location usingthe processed amplitude. Other algorithms for using the amplitude of thefirst and second signals to enhance any amplitude difference in creatingthe image of the location after medical treatment are left to theartisan.

[0138] In another example of the twentieth method of the invention, stepc) includes creating an image of the location using at least the phaseof the first signal and the phase of the second signal. In onevariation, step c) calculates the difference in the phase between thefirst and second signals. In one modification, step c) uses thecalculated phase difference and uses one of the phases of one of thefirst and second signals. In one implementation, step c) calculates thesum of the one phase and a function of the calculated phase difference.In one illustration of a first signal phase of 6 degrees and a secondsignal phase of 7 degrees, step c) calculates the phase difference, addsthe difference to the second signal phase creating a processed phase of8 degrees, and creates the image of the location using the processedphase. Other algorithms for using the phase of the first and secondsignals to enhance any phase difference in creating the image aftermedical treatment are left to the artisan.

[0139] In an additional example of the twentieth method of theinvention, step c) includes creating an image of the location using atleast the amplitude and the phase of the first signal and the amplitudeand phase of the second signal. In one variation step c) combines thediscussions in the previous two paragraphs, as is within the ordinarylevel of skill of the artisan.

[0140] In one application of the twentieth method and examples, etc.thereof, the first signal of step a) has a first frequency (e.g., afirst center frequency having a sigma) and the second signal of step b)has a second frequency (e.g., a second center frequency having a sigma)which is different from the first frequency (meaning, for example, thatthe center frequencies are different). In the same or a differentapplication, the medical treatment is ultrasound medical treatment. Inthe same or a different application, steps a) through c) are repeatedfor different locations to image the patient tissue, wherein the imageof the patient tissue includes medically-treated locations andmedically-untreated locations. In one enablement of the twentieth methodof the invention, the image of the patient tissue is visually displayedon a monitor. In another enablement, the image remains as an image mapin a computer without being displayed on a monitor. In one extension ofthe twentieth method, additional signals are obtained between steps a)and b) which are also used in creating the image of the location in stepc).

[0141] Applicants were the first to realize that changes in patienttissue because of medical treatment of patient tissue, such asultrasound medical treatment, which affect the amplitude and/or phase ofultrasound imaging signals can be used to enhance the ultrasound imagedifferences of medically-treated patient tissue from surroundinguntreated tissue. Applicants have theorized that using differentfrequencies for the two signals can enhance amplitude and/or phasedifferences for medically treated and untreated tissue and can be usedto enhance the ultrasound image differences of medically-treated patienttissue from surrounding untreated tissue. Advantages of the twentiethmethod and examples, etc. thereof include, in one application, betterultrasound image contrast between treated and untreated patient tissueproviding better monitoring during patient treatment.

[0142] Other medical treatments applicable to the twentieth methodinclude, without limitation, other thermal ablation techniques such asradio-frequency, laser, and microwave medical treatments and chemicalablation techniques such as ethanol and chemo-therapeutics (includinganti-cancer drugs). Other optional steps in the twentieth method includeusing signal smoothing techniques, as are known to those skilled in theart.

[0143] It is understood that any one or more of the previously-describedembodiments, expressions of embodiments, examples, methods, etc. can becombined with any one or more of the other previously-describedembodiments, expressions of embodiments, examples, methods, etc. Forexample, and without limitation, any of the end effectors can be used inany of the methods, any of the transducer arrangements can be used inany of the end effectors, and any appropriate methods can be combinedsuch as combining the seventeenth and twentieth methods, etc.

[0144] The foregoing description of several expressions of embodimentsand methods of the invention has been presented for purposes ofillustration. It is not intended to be exhaustive or to limit theinvention to the precise forms and procedures disclosed, and obviouslymany modifications and variations are possible in light of the aboveteaching. For example, as would be apparent to those skilled in the art,the disclosures herein of the ultrasonic systems and methods have equalapplication in robotic assisted surgery taking into account the obviousmodifications of the invention to be compatible with such a roboticsystem. It is intended that the scope of the invention be defined by theclaims appended hereto.

What is claimed is:
 1. A method for medical treatment of a patient comprising the steps of: a) obtaining an ultrasound imaging transducer assembly; b) inserting the transducer assembly into a gastrointestinal area of the patient; c) guiding the transducer assembly within the gastrointestinal area; d) identifying patient tissue in the gastrointestinal area for medical treatment; e) staging the medical treatment from ultrasound imaging using the transducer assembly; and f) medically treating the patient tissue according to the staging of step e).
 2. A method for ultrasound medical treatment of a patient comprising the steps of: a) obtaining an end effector having an ultrasound imaging and medical-treatment transducer assembly; b) inserting the end effector into a gastrointestinal area of the patient; c) guiding the transducer assembly within the gastrointestinal area; d) identifying patient tissue in the gastrointestinal area for medical treatment; e) staging the medical treatment from ultrasound imaging using the transducer assembly; and f) medically treating the patient tissue with ultrasound using the transducer assembly according to the staging of step e).
 3. The method of claim 2, wherein the patient tissue is gastroesophageal tissue containing a lesion, and wherein step e) ultrasonically substantially ablates the lesion.
 4. The method of claim 3, wherein the gastroesophageal tissue contains a blood vessel supplying blood to the lesion, and wherein step e) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel.
 5. The method of claim 2, wherein the patient tissue is liver tissue containing a lesion and a blood vessel supplying blood to the lesion, and wherein step e) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel.
 6. The method of claim 2, wherein the patient tissue is liver tissue containing a lesion, and wherein step e) ultrasonically substantially ablates the lesion.
 7. The method of claim 6, wherein the liver tissue contains a blood vessel supplying blood to the lesion, and wherein step e) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel.
 8. A method for ultrasound medical treatment of a patient comprising the steps of: a) obtaining an end effector having an ultrasound imaging and medical-treatment transducer assembly; b) inserting the end effector into a gastrointestinal area of the patient; c) guiding the transducer assembly within the gastrointestinal area; d) identifying patient tissue in the gastrointestinal area for medical treatment at least in part from ultrasound imaging using the transducer assembly; e) staging the medical treatment from ultrasound imaging using the transducer assembly, and f) medically treating the patient tissue with ultrasound using the transducer assembly according to the staging of step e).
 9. The method of claim 8, wherein the patient tissue is gastroesophageal tissue containing a lesion, and wherein step f) ultrasonically substantially ablates the lesion.
 10. The method of claim 8, wherein the gastroesophageal tissue contains a blood vessel supplying blood to the lesion, and wherein step f) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel.
 11. The method of claim 8, wherein the patient tissue is liver tissue containing a lesion and a blood vessel supplying blood to the lesion, and wherein step f) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel.
 12. The method of claim 8, wherein the patient tissue is liver tissue containing a lesion, and wherein step f) ultrasonically substantially ablates the lesion.
 13. The method of claim 12, wherein the liver tissue contains a blood vessel supplying blood to the lesion, and wherein step f) ultrasonically treats the blood vessel to substantially stop the supply of blood to the lesion from the blood vessel. 